Technical documentation: Your ticket to the in vitro diagnostics market

In vitro diagnostic medical devices (IVDs) are the specialists among medical devices: complex and effective. As they take on a special role, IVDs are regulated separately. (IVDR (EU) 2017/746 effective May 26, 2022, until now by IVDD 98/79/EG).
The efficient interaction of different quality management processes is to ensure safe and effective devices that remain safe and effective throughout their entire life cycle. With the technical documentation you prove against third parties that these processes are conducted in a correct manner and conform to the respective target country. We support you on all levels and at any given time in the product life cycle to fulfill this requirement.

Regardless of its risk class, any in vitro diagnostic medical device (IVD) you intend to launch on the market always requires technical documentation.
The technical documentation includes all details about the in vitro diagnostic medical device. In addition to all information about development, manufacturing, verification and validation, it also includes the actual technical specifications as well as information about the application of the device.

By means of the technical documentation you as the manufacturer establish proof that your IVD conforms to the underlying regulations of the individual countries. Furthermore, it confirms compliance with the basic safety and performance requirements for European CE marking. It is the prerequisite for the approval of a device in the relevant target country. After a device’s final application, the technical documentation must be kept available for inspection by the surveillance authorities for a period of at least ten years.

Classification of IVDs

Under the IVD directive, devices are classified in accordance with Annex II into list A or list B devices, or devices for self application and others. With the introduction of the IVD regulation, devices are separated into four classes A, B, C or D based on seven classification rules. Depending on the classification of the in vitro diagnostic medical device, different requirements regarding the conformity assessment procedure and the involvement of the notified body have to be observed. (Link to classification rules) More about IVDR

Keep track of everything: Your IVDR schedule

Between directive (IVDD) and regulation (IVDR):
What do you have to do?

UDI, EUDAMED, software, classification, involvement of the notified body for a majority of devices... These are some keywords in the current discussion and in view of the IVDR taking effect, the major obstacles that manufacturers have to overcome. In addition, these issues are interdependent, i.e. the results of risk management influence software development, UDI requirements affect labeling processes, post market surveillance needs must be represented in the QMS – in short: Regulatory is teamwork.

Not really much is left of the five-year transition period from when the regulation was published in 2017 to its enforcement in 2022. And if we just do some simple math together: Assuming there are 50 product files and you need only 200 hours each for revision, you end up with a total of 10,000 hours – more than one person could have handled in five years.

You need support? We look forward to contributing to your team success!

IVD classification: Everything planned already?

Especially the new classification rules and the resulting increase in regulation through the notified body confront manufacturers with tremendous challenges. Considering the defined timelines, you need a solid and elaborate plan how to revise the technical documentation.

Your advantages when working with us

  • We are your reliable partner for adapting your QM processes and developing and revising the technical documentation of your IVDs.
  • You receive all documents for your technical documentation based on your templates and ready to be signed for approval (international) or product certification (EU).
  • Our experience with technical documentation and the certification process as well as with verification and validation ensures that we reach your goals quickly and efficiently.
  • Our GAP analyses deliver recommendations on all levels of your regulatory activities (QM system, technical documentation, product portfolio).

Our services in detail

Develop and maintain the technical documentation
  • Creating the content of the technical documentation (EU and international) – conforming to applicable standards and laws,
  • Checking the technical documentation of IVDs already available on the market against current regulatory requirements,
  • Communicating with notified bodies and test laboratories.

Revising and adapting quality management
  • Analyzing the need for changes,
  • Adapting the processes.

In addition we offer consulting and support for:
  • Risk management process in accordance with ISO 14971,
  • Usability in accordance with ISO 62366,
  • Software development process in accordance with IEC 62304,
  • Performance evaluation, verification and validation.

More of what we can do for you and your technical documentation

Fit for the future with the Metecon Academy

Each of our workshops and in-house courses provides sustainable knowledge and know-how in the areas of technical documentation, regulatory affairs and QM and is always exactly tailored to your needs.

Our customers use our workshops with our experts:
to keep themselves and their team up to date with the latest knowledge and/or to go into intensive exchange with us and gain clarity in the face of a current challenge about a specific description of objectives and the project strategy.

Through the operation of our own trainee academy, our comprehensive training material is always up to date.

Let us find out together what your team needs!

Workshop topics:

  • Implementation of IVDR for technical documentation and QM
  • Risk management
  • Usability
  • Biological safety
  • Clinical affairs
  • Software
  • Approval
  • Quality management

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